Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)

NCT04397692 | Terminated DMC FDA Device

• 1 other identifier: BAI_COV19_01_US
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.

Conditions

Corona Virus Infection; COVID-19; SARS-CoV 2; Nitric Oxide; Respiratory Disease; Pneumonia, Viral; Inhaled Nitric Oxide

Keywords

COVID-19; Coronavirus; Inhaled Nitric Oxide; iNO; SARS-coronavirus; Virus

Outcome Measures

Primary Outcomes (1)

• Time to deterioration

  Time to deterioration measured by need for NIV, HFNC or intubation

  14 Days

Secondary Outcomes (4)

• Time to NIV

  14 Days

• Time to HFNC

  14 Days

• Time to intubation

  14 days

• Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%

  14 days

Other Outcomes (4)

• Need for supplemental oxygen

  14 days

• Change in viral load

  30 days

• Duration of the Hospital Length of Stay (LOS)

  14 days

Study Arms (2)

Inhaled NO delivered using LungFit™ in addition to SST

EXPERIMENTAL

Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care.

Device: Nitric Oxide delivered via LungFit™ system

Standard of care

NO INTERVENTION

Control - Standard of care

Interventions

Nitric Oxide delivered via LungFit™ system DEVICE

Patients will receive inhalations of 80 ppm for 40 min 4 times a day

Inhaled NO delivered using LungFit™ in addition to SST

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
• Patients with oxygen saturation less than 93 % on room air
• Shortness of breath, with symptom onset within the previous 8 days.
• Female subjects of childbearing potential should take adequate measures to avoid pregnancy
• Signed informed consent by the subject

You may not qualify if:

• Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
• Diagnosis of acute respiratory distress syndrome
• Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
• Patients receiving drugs that have contraindications with NO.
• Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
• Patients with active pulmonary malignancy or lung transplant
• Patients with a history of frequent epistaxis or significant hemoptysis

Sponsors & Collaborators

• Beyond Air Inc.: lead

Study Sites (1)

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Respiration Disorders; Pneumonia, Viral; Severe Acute Respiratory Syndrome; Virus Diseases

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ashik Tal, MD

  Beyond Air

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 21, 2020
• Study Start: June 13, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)